ProtoPharma Engineering GmbH was founded almost three decades ago and has its roots in pharmaceutical production, logistics and sales. GMP is therefore in our blood and we are happy to make our many years of experience available to our customers in the pharmaceutical industry so that they can meet the constantly growing international quality requirements.
“The global regulatory environment is changing rapidly. It is a challenge for many companies to meet the increasing GMP requirements. We help you to maintain an overview and to produce efficiently and compliantly in the long term.”
The global regulatory environment is changing rapidly. It is a challenge for many companies to meet the increasing GMP requirements. With our knowledge of the current international GMP regulations and the relevant industry standards, we help our customers to successfully pass inspections and audits and also support them with technology transfers.
In order to guarantee GMP compliance in all functions and phases, we offer our customers consulting services across the entire product life cycle.
When introducing or optimizing a quality management system (QMS), we attach great importance to the balance between regulatory requirements and practical operational requirements. Of course, we can also tailor our consulting activities to small and medium-sized companies.
For the fulfillment of the Good Practice (GxP) requirements of the FDA, EU and ICH you need competent contact persons. Our experts will be happy to help you in the area of GMP compliance.
ProtoPharma’s quality management system (QMS) is a process-oriented, integrated management system based on the requirements of ISO 9001 quality management systems.
By implementing and fulfilling the QMS guidelines, ProtoPharma ensures that our services always meet the expectations of customers, the regulatory requirements and ProtoPharma’s own requirements.
Quality assurance at ProtoPharma means: